Evidence map›Paper›PMID 34670762›Full record

ArticleBMJ open2021

Cross-sectional study to develop and describe psychometric characteristics of a patient-reported instrument (PROFFIT) for measuring financial toxicity of cancer within a public healthcare system.

Silvia Riva, Laura Arenare, Massimo Di Maio, Fabio Efficace, Vincenzo Montesarchio, Luciano Frontini, Diana Giannarelli, Jane Bryce, Laura Del Campo, Francesco De Lorenzo and 17 more

Registry-linked trialAbstract read
In one paragraph

Article in BMJ open, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03473379 (Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy), which is not on this map. Cited by 30 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
30citing papers in PubMed, 5 pooled it
–field-weighted citation impact
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT03473379 unknown statusnot on this map

Development and Validation of a Tool for Patient-reported Assessment of Cancer-related Financial Toxicity - Italy

TypeobservationalSponsorNational Cancer Institute, NaplesRan2018 to 2024Enrolled440ConditionsCancer
3 · Its place in the literature

Who cites it

30 citing papers in PubMed, 5 syntheses or guidelines pooled it.

  1. Pooled it
  2. Pooled it
  3. Pooled it
  4. Measuring financial toxicity in head and neck cancer: a systematic review.Acta otorhinolaryngologica Italica : organo ufficiale della Societa italiana di otorinolaringologia e chirurgia cervico-facciale · 2024
    Pooled it
  5. Pooled it
  6. Constructing the scale to measure financial toxicity in cancer patients for Low-middle income countries (FT-LM) by using the modified Delphi method.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2026
    Article
  7. Article
  8. Article
  9. Review
  10. Review
  11. Article
  12. Article
  13. Article
  14. Assessment of financial toxicity in patients with cancer in Slovenia.Supportive care in cancer : official journal of the Multinational Association of Supportive Care in Cancer · 2025
    Article
  15. Article
  16. Allies not enemies-creating a more empathetic and uplifting patient experience through technology and art.Strahlentherapie und Onkologie : Organ der Deutschen Rontgengesellschaft ... [et al] · 2025
    Review
  17. Article
  18. Article
  19. Financial Toxicity and Kidney Disease in Children and Adults: A Scoping Review.International journal of nephrology and renovascular disease · 2025
    Review
  20. Detection of Financial Toxicity in Italian Uremic Patients: A Single Center Cross-Sectional Study.International journal of nephrology and renovascular disease · 2025
    Article
4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

27 authors.

Silvia RivaPsychology and Pedagogic Science, St Mary's University, Twickenham, London, UK.
Laura ArenareUnità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Massimo Di MaioDipartimento di Oncologia, AO Ordine Mauriziano, Università degli Studi di Torino, Torino, Italy.ORCID 0000-0001-8906-3785
Fabio EfficaceHealth Outcomes Research Unit, Gruppo Italiano per le Malattie Ematologiche dell'Adulto (GIMEMA), Roma, Italy.
Vincenzo MontesarchioOncologia, AORN Ospedali dei Colli, Napoli, Italy.
Luciano FrontiniFederation of Italian Cooperative Oncology Groups (FICOG), Milano, Italy.
Diana GiannarelliUnità di Biostatistica, Istituto Nazionale per lo Studio e la Cura dei Tumori Regina Elena, IRCCS, Roma, Italy.
Jane BryceUnità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Laura Del CampoFederazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Roma, Italy.
Francesco De LorenzoAssociazione Italiana Malati di Cancro (AIMAC), Roma, Italy.
Elisabetta IannelliFederazione Italiana delle Associazioni di Volontariato in Oncologia (FAVO), Roma, Italy.
Francesca TraclòAssociazione Italiana Malati di Cancro (AIMAC), Roma, Italy.
Lara GittoDipartimento di Economia, Università degli Studi di Messina, Messina, Italy.
Claudio JommiCERGAS (Centre for Health and Social Care Management), Università Bocconi, Milano, Italy.
Concetta Maria VaccaroArea Welfare e Salute, Censis - Centro Studi Investimenti Sociali, Roma, Italy.
Daniela BarberioPsiconcologia Clinica, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Saverio CinieriOncologia Medica, Ospedale Perrino, Brindisi, Italy.
Camillo PortaOncologia Medica, Fondazione IRCCS Policlinico San Matteo, Pavia, Italy.
Lucia Del MastroBreast Unit, IRCCS Ospedale Policlinico San Martino, Genova, Italy.
Vittorina ZagonelOncologia 1, Istituto Oncologico Veneto, IOV, IRCCS, Padova, Italy.
Alessio Aligi CogoniOncologia Medica, AOU di Sassari, Sassari, Italy.
Roberto BordonaroOncologia, ARNAS Garibaldi-Nesima, Catania, Italy.
Anna GimiglianoUnità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Maria Carmela PiccirilloUnità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy.
Lorenzo GuizzaroStatistica Medica, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.
Ciro Gallo *Statistica Medica, Università degli Studi della Campania Luigi Vanvitelli, Napoli, Italy.ORCID 0000-0002-7939-3104
Francesco Perrone *Unità Sperimentazioni Cliniche, Istituto Nazionale Tumori IRCCS Fondazione Pascale, Napoli, Italy f.perrone@istitutotumori.na.it.ORCID 0000-0002-9738-0526

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectivesTo measure and explain financial toxicity (FT) of cancer in Italy, where a public healthcare system exists and patients with cancer are not expected (or only marginally) to pay out-of-pocket for healthcare.

settingTen clinical oncological centres, distributed across Italian macroregions (North, Centre, South and Islands), including hospitals, university hospitals and national research institutes.

participantsFrom 8 October 2019 to 11 December 2019, 184 patients, aged 18 or more, who were receiving or had received within the previous 3 months active anticancer treatment were enrolled, 108 (59%) females and 76 (41%) males.

interventionA 30-item prefinal questionnaire, previously developed within the qualitative tasks of the project, was administered, either electronically (n=115) or by paper sheet (n=69). PRIMARY AND SECONDARY OUTCOME MEASURES: According to the protocol and the International Society for Pharmacoeconomics and Outcomes Research methodology, the final questionnaire was developed by mean of explanatory factor analysis and tested for reliability, internal consistency (Cronbach's α test and item-total correlation) and stability of measurements over time (test-retest reliability by intraclass correlation coefficient and weighted Cohen's kappa coefficient).

resultsAfter exploratory factor analysis, a score measuring FT (FT score) was identified, made by seven items dealing with outcomes of FT. The Cronbach's alpha coefficient for the FT score was 0.87 and the item-total correlation coefficients ranged from 0.53 to 0.74. Further, nine single items representing possible determinants of FT were also retained in the final instrument. Test-retest analysis revealed a good internal validity of the FT score and of the 16 items retained in the final questionnaire.

conclusionsThe Patient-Reported Outcome for Fighting FInancial Toxicity (PROFFIT) instrument consists of 16 items and is the first reported instrument to assess FT of cancer developed in a country with a fully public healthcare system. TRIAL REGISTRATION NUMBER: NCT03473379.

Indexed as

NeoplasmsPatient Reported Outcome MeasuresCross-Sectional StudiesDelivery of Health CareFemaleHumansMalePsychometricsReproducibility of ResultsSurveys and Questionnaireshealth economicsoncologyqualitative researchquality in health care

Identifiers

PMID34670762
PMCPMC8529986

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.